Friday, August 29, 2014

Clinical trials to see if nutty ideas work

Don't laugh, because our tax money has been paying for such “research” for years. A recent paper outlines a little of the history, gives some examples and calls for it to stop.

From the opening of the paper:

A new phenomenon in clinical trials has arisen over the past 20 years. Complementary and alternative medicine (CAM) or integrative medicine (IM) modalities based on principles that bespeak infinitesimally low prior probability of success or that even violate well-established laws of physics and chemistry are being tested in randomized clinical trials (RCTs). CAM proponents frequently justify such RCTs by arguing that they will finally settle once and for all which CAM or IM modalities do and do not work. Our response is that this is a misguided viewpoint that has led to the infiltration of pseudoscience in academic medicine.

The authors give some examples which illustrate the absurdity of what's going on, then move to a discussion of the role of evidence based medicine, stating:

Evidence-based medicine (EBM) assumes that treatments do not reach the stage of RCTs without having amassed sufficient preclinical evidence to justify the effort, time, and expense of RCTs, as well as the use of human subjects.

Indeed that must have been the assumption of the founders of EBM in 1992 when the movement was launched. It must never have occurred to them that nutty ideas would someday be the subject of clinical trials. Hence the processes of EBM had no formal mechanism to distinguish sense from nonsense. Who knew, early in the movement, that such a mechanism would be needed? But, as illustrated in the paper, the assumption proved to be naïve thus exposing a major failure of EBM. I addressed that failure here and in several other posts.

Doing clinical trials to study implausible claims appears to be a violation of the Declaration of Helsinki, as the authors point out:

Indeed, so integral to this process is biological plausibility based on preclinical data that the Declaration of Helsinki [8] states, ‘medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation’.

The full text of the paper is available for free and is worth reading in its entirety for all the richness there.